The Supreme Court has for now preserved access to the abortion medication mifepristone—a win for the biopharma world that rallied to support the FDA’s authority to approve drugs. But the women behind the unprecedented letter campaign and amicus brief are not yet breathing a sigh of relief.
“A lot of us were a little hesitant to get too excited at the news on Friday, simply because that just means the discussion needs to continue and that this is going to take its time to work its way through the courts,” Julia Owens, Ph.D., told Fierce Biotech in an interview.
Owens, CEO of stealth, RNA-focused biotech Ananke Therapeutics, is a member of the Biotech Sisterhood, a group of female executives in the industry who organize meetups and retreats. In the wake of Roe v. Wade being overturned last year, however, the group’s members have led several high-profile campaigns to push back and protect abortion rights.
Leading the call for support when a Texas judge blocked the FDA’s approval of mifepristone on April 7 were Owens, former InCarda Therapeutics CEO Grace Colón, Ph.D., ReCode Therapeutics CEO Shehnaaz Suliman, M.D., former Blackfynn CEO Amanda Banks, M.D., and many others. Owens said that Banks and Suliman were ready with the letter when the Texas judge handed down the original ruling. Then the sisterhood simply hit the phones to gather support.
The letter ended up with 700 signatures from executives and industry members that included names like Pfizer CEO Albert Bourla, Ph.D., and former Alnylam CEO John Maraganore, Ph.D. Iolyx Therapeutics CEO Elizabeth Jeffords and Colón engaged a law firm to get the legal briefs going to support the federal government and FDA’s appeal, with 270 signatories joining the one that was sent to the Supreme Court. On April 21, the Supreme Court voted 7-2 to keep the abortion pill broadly available as the legal battle over the approval status plays out in the lower courts.
“A lot of us were afraid of a worse outcome,” Owens said of the high court’s ruling. While there’s a slight feeling of relief, Owens said there’s still a lot of fight to come, and the pill is still in peril.
What galvanized so many biopharma executives this time is that the decision from U.S. District Judge Matthew Kacsmaryk undermined the FDA’s authority to approve medicines, according to the letter and various briefs.
“As someone who works in a small early-stage company that’s raising capital, investors need to be able to trust that when my product moves along, that the FDA is going to be the one who’s judging this not an activist judge with little to no scientific training,” Owens said.
This angle was easier to gather support for, whereas many people in business often do not want to wade into the politically fraught issue of abortion rights. But when the ripple effect of a ruling begins to spread to harm businesses, “that compelled folks to speak up,” Owens said.
Owens doesn’t want the issue of abortion rights to be lost, even though the letter was framed around the potential harms that could be done to drug development if the FDA’s regulatory process is undermined.
“There’s a whole parallel but obviously related issue of the broader attack on reproductive rights and what’s going on at the state level, but I do think the industry is speaking up largely to protect our science-based regulatory paradigm,” Owens said.
The next date for the court matter is May 17 at the U.S. Court of Appeals for the Fifth Circuit. Meanwhile, the “threat is very much real,” Owens said. The courts have not yet answered the question of whether a judge can overrule an FDA approval decision. The biotech leaders plan to file more amicus briefs to support the appeal.